Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS)
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ClinicalTrials.gov Identifier: NCT00242944 |
Recruitment Status :
Completed
First Posted : October 21, 2005
Last Update Posted : December 17, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Disease Hypercholesterolemia | Drug: Pitavastatin Drug: Atorvastatin | Phase 4 |
Previous mega trials have demonstrated that lipid lowering therapy with HMG-CoA reductase inhibitors (statins) reduces the incidence of major cardiovascular events by one-third, thus, the benefit of lipid lowering therapy has been substantiated. Such a benefit is significant especially for patients with coronary heart disease (CHD). The third report of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP-III) has suggested the advantage of more intensive lipid lowering therapy with a goal of reducing LDL-C below 70 mg/dL for such patients categorized as very high risk. In Japan, Japan Atherosclerosis Society (JAS) Guidelines for Diagnosis and Treatment of Atherosclerotic Cardiovascular Diseases 2002 have recommended that an LDL-C goal for patients with coronary heart disease should be below 100 mg/dL. However, there is no satisfactory evidence yet for the need to lower LDL-C level less than the goal prescribed in Japan.
Recently, research on diagnosis of coronary plaque has shown significant advances. The REVERSAL study in patients with a history of CHD, by diagnosis with intravascular ultrasound, suggested that intensive lipid lowering therapy with atorvastatin (80 mg/day) was associated with no growth of plaque (-0.4% compared to baseline), versus therapy with pravastatin (40 mg/day) which showed a slight increase (2.7%) in plaque volume over 18 months. In Japan, the ESTABLISH study, a single center study, indicated that early intensive lipid lowering therapy with atorvastatin (20 mg/day) could induce a significant reduction in plaque volume in patients with acute coronary syndrome. However, this benefit has not been verified in multicenter trials in Japan. Further, no comparative investigation into the effect of various concomitant drugs on coronary plaque has been done.
Pitavastatin is a chemically synthesized statin in Japan which has been marketed since late 2003. Pitavastatin has an LDL-C lowering effect as strong as atorvastatin and also has a superior HDL-C elevating effect; meanwhile, the effect of pitavastatin on coronary plaque has not been reported.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 307 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Pitavastatin
|
Drug: Pitavastatin
Pitavastatin 4mg per day |
Active Comparator: 2
Atorvastatin
|
Drug: Atorvastatin
Atorvastatin 20mg per day |
- plaque volume [ Time Frame: one year ]
- total cholesterol (TC) [ Time Frame: one year ]
- low-density lipoprotein (LDL)-cholesterol (LDL-C) [ Time Frame: one year ]
- high-density lipoprotein (HDL)-cholesterol (HDL-C) [ Time Frame: one year ]
- HDL2-C [ Time Frame: one year ]
- HDL3-C [ Time Frame: one year ]
- remnant like particles-cholesterol (RLP-C) [ Time Frame: one year ]
- small dense LDL-C [ Time Frame: one year ]
- non-HDL-C [ Time Frame: one year ]
- LDL-C/HDL-C [ Time Frame: one year ]
- apolipoprotein AI (apoA-I) [ Time Frame: one year ]
- apoB [ Time Frame: one year ]
- apoE [ Time Frame: one year ]
- apoB/apoA-I [ Time Frame: one year ]
- malondialdehyde-modified LDL (MDA-LDL) [ Time Frame: one year ]
- phospholipids [ Time Frame: one year ]
- lipoprotein(a) [Lp(a)] [ Time Frame: one year ]
- high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: one year ]
- pentraxin 3 [ Time Frame: one year ]
- leukocytes [ Time Frame: one year ]
- coronary plaque area at culprit region [ Time Frame: one year ]
- minimal lumen diameter (MLD) and percent (%) stenosis [ Time Frame: one year ]
- major adverse cardiac events (cardiac death, Q or non-Q myocardial infarction and target vessel revascularization) [ Time Frame: one year ]
- number of deaths from any cause [ Time Frame: one year ]
- frequency of adverse drug reactions [ Time Frame: one year ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial
- Patients 20 years or older at the time of their consent
-
Patients with hypercholesterolemia as defined by any of the following criteria:
- TC >= 220 mg/dL;
- LDL-C >= 140 mg/dL;
- Cholesterol-lowering treatment is necessary in accordance with the investigator's judgement when LDL-C >= 100 mg/dL or TC >= 180 mg/dL.
- Patients who have been diagnosed with acute coronary syndrome
- Patients with successful percutaneous coronary intervention (PCI) by intravascular ultrasound (IVUS) guidance
- Patients having coronary plaques (>= 500 µm in thickness or 20% or more in % plaque) at >= 5 mm from the previously treated area in the same branch of coronary artery
Exclusion Criteria:
- Patients with bypass graft or in-stent restenosis at the site of PCI
- Patients who had received PCI on the lesion in the past where the evaluation of coronary plaque volume is planned
- Patients who had plaques in a non-culprit site and might receive PCI during the treatment period
- Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors)
- Patients with familial hypercholesterolemia
- Patients with cardiogenic shock
- Patients receiving cyclosporine
- Patients with any allergy to pitavastatin or atorvastatin
- Patients with hepatobiliary disorders
- Pregnant women, women suspected of being pregnant, or lactating women
- Patients with renal disorders or undergoing dialysis
- Patients who are ineligible in the opinion of the investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242944
Japan | |
Juntendo University School of Medicine | |
Bunkyo-ku, Tokyo, Japan, 113-8421 | |
Yamaguchi University Graduate School of Medicine | |
Ube, Yamaguchi, Japan, 755-8505 | |
Kyoto University Graduate School of Medicine | |
Kyoto, Japan, 606-8507 |
Study Chair: | Masunori Matsuzaki, MD, PhD | Professor of Medicine, Department of Cardiovascular Medicine, Yamaguchi University Graduate School of Medicine | |
Principal Investigator: | Hiroyuki Daida, MD | Professor of Medicine, Department of Cardiovascular Medicine, Juntendo University School of Medicine | |
Principal Investigator: | Takeshi Kimura, MD | Associate Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Masunori Matsuzaki, Yamaguchi University Graduate School of Medicine |
ClinicalTrials.gov Identifier: | NCT00242944 |
Other Study ID Numbers: |
H17-49 |
First Posted: | October 21, 2005 Key Record Dates |
Last Update Posted: | December 17, 2009 |
Last Verified: | June 2008 |
Acute coronary syndrome Hypercholesterolemia Primary coronary intervention Hydroxymethylglutaryl-CoA reductase inhibitors |
coronary plaque Angioplasty, Transluminal, Percutaneous Coronary Ultrasonography, Interventional |
Acute Coronary Syndrome Coronary Disease Hypercholesterolemia Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Atorvastatin Pitavastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |